This invention relates to procedures and apparatus for treating obesity in human patients.
In the past, rather drastic surgical procedures have been employed to treat morbidly or mortally obese patients, i.e., patients whose body weight is at least twice their appropriate weight. One set of surgical procedures induces a pathophysiologic abnormality of the gastrointestinal tract by gastric or jejunoileal bypass operations in which as much as 95% of the tract is surgically bypassed. These procedures result in a patient who is a metabolic cripple having surgically induced malabsorption, and are associated with long term complications often requiring additional surgical procedures. The jejunoileal bypass, for example, has been used extensively in this country and around the world. This procedure bypasses about 95% of the small bowel, leaving about 40 cm. of functioning jejunum and ileum. The physiologic effect of this is massive diarrhea and malabsorption of nutrients, leading to weight loss secondary to poor absorption of nutrients, as well as aversion to eating. The procedure is performed an estimated five thousand to twenty thousand times per year in the United States, but has been abandoned by many institutions, including the Cleveland Clinic, because of unacceptable operative mortality averaging 6% nationwide, as well as severe complications including wound infection and breakdown, progressive liver failure, hypocalcemia, calcium oxalate urinary calculi and bypass enteropathy. Mechanical problems such as intestinal obstruction and hernia formation are frequent.
Approximately 32% of the patients having jejunoileal bypass operations are rehospitalized within one year. These operations have also been associated with liver dysfunctions most likely caused by the preferential absorption of carbohydrates in the remaining small bowel, with resulting relative protein starvation.
Because of all these problems, attention has been directed toward gastric surgical procedures to induce weight loss. A gastroplasty procedure was performed by Mason et al. (University of Iowa) to change the shape of the stomach but abandoned because of the technical difficulty of obtaining a proper partial outflow obstruction of the proximal gastric pouch. Instead, these investigators now recommend a 90% gastric bypass in which the proximal 10% of the stomach is anastomosed to the jejunum. This procedure is associated with a 3% operative mortality, as well as frequent would infections, anastomotic breakdowns, and a frequent need to revise the anastomosis. Other approaches to reducing the size of the stomach to cause weight loss include that of Wilkinson (Cited in Alden) who performed a "gastric inversion" with Marlex mesh wrapping in 2 cases, and that of Tretbar, who performed a gastric plication in 20 cases.
Another set of surgical procedures has involved oral surgical techniques to wire shut a patient's jaws to reduce food intake. This involves the serious possibility that any vomiting which may occur can result in aspiration of food and gastric secretions into the lungs.
Non-surgical treatment of obesity by the use of non-nutritive means such as methyl cellulose to fill the stomach is also known. For example, the use of tablets is known which after ingestion together with a fluid swell to a soft, stomach-filling bolus. However, it is appreciated that these means are not usually a satisfactory treatment for patients having the extreme disorder here described.
Mechanical apparatuses are known for insertion through the esophagus into the stomach to conform to the internal shape of the stomach, for example, to fill the stomach and to prevent hemorraging into the stomach from blood vessels at the stomach wall. For example, U.S. Pat. Nos. 3,046,988 and 3,055,371 describe the use of esophago-gastric balloons for such purposes. However, these apparatuses, when utilized, would obstruct the esophagus and, by filling the stomach, interfere with all ingestion of food.
Incontinence devices are also known which may be non-surgically inserted into a patient through an external orifice to entirely seal off passages to an internal organ. For example, U.S. Pat. No. 3,841,304 discloses an inflatable balloon-like bulb for non-surgical partial insertion into the bladder of a female to temporarily seal the entrance from that organ to the urethra so as to restore control over the flow of urine from the bladder. U.S. Pat. No. 3,646,929 discloses a more complex device for vaginal insertion to accomplish control over bladder emission. This device can be made to expand so that a flexible diaphragm displaces the urethra and bladder neck and prevents emptying of the bladder. In both of these cases the control of these devices is accomplished by means of an inflation bulb extending outside the patient's body.
It has been known to place an inflatable apparatus within a patient's abdomen during surgery for use as a retractor to retain the viscera during suturing, for example, as described in U.S. Pat. No. 3,863,639. Such an apparatus, however, is not an implant apparatus, i.e., it is not adapted to remain entirely within the patient postoperatively, and plays no direct role in the control of any disorder.
Accordingly, an object of the invention is to treat mortally or morbidly obese patents without including malabsorption of nutrients in the gastrointestinal tract.
Another object of the present invention is to avoid the complications associated with bypass operations on the gastrointestinal tract.
A further object of the invention is to treat mortally or morbidly obese patients whereby the patient's stomach may be compressed to a controlled degree and adjustments made from time to time in the amount of compression by outpatient treatment.
A still further object of the invention is to provide a relatively simple procedure for treating mortally or morbidly obese patients whereby a feeling of satiety from hunger and a reduction in the capacity of the stomach is produced without intrusion into the gastrointestinal tract.
A still further object of the invention is to provide a surgical implant apparatus that is simple to manufacture for the control of morbid obesity in patients.
These and other objects of the invention will appear more fully in the following specification taken with the accompanying drawings.